01 3Patheon Italia S.p.A.
01 3romiplostim
01 3U.S.A
NDC Package Code : 68225-050
Start Marketing Date : 2008-08-25
End Marketing Date : 2025-12-31
Dosage Form (Strength) : INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION (0.6mg/1)
Marketing Category : DRUG FOR FURTHER PROCESSING
NDC Package Code : 68225-104
Start Marketing Date : 2019-08-02
End Marketing Date : 2025-12-31
Dosage Form (Strength) : INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION (125ug/.25mL)
Marketing Category : DRUG FOR FURTHER PROCESSING
NDC Package Code : 68225-049
Start Marketing Date : 2008-08-25
End Marketing Date : 2025-12-31
Dosage Form (Strength) : INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION (0.4mg/1)
Marketing Category : DRUG FOR FURTHER PROCESSING
100
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A Su 5416 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Su 5416, including repackagers and relabelers. The FDA regulates Su 5416 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Su 5416 API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Su 5416 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Su 5416 API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture Su 5416 as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
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